Napoleon Measurement of Gastrojejunal Anastomosis

Gastric Bypass Clinical Trial

Official title:

Feasibility of a New Method Named Napoleon to Measure Gastrojejunal Anastomosis in Gastric Bypass Patients With Weight Regain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04832282
• Other study ID #: 20-01436
• Status: Recruiting
• Phase: Early Phase 1
• Start date: June 14, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: January 2024
• Source: NYU Langone Health
• Contact: Violeta Popov, MD
• Phone: 212-686-7500
• Email: Violeta.Popov[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a clinical trial assessing the feasibility of the Napoleon device for measuring the gastrojejunal anastomosis (GJA). The study population is Roux-en-Y gastric bypass (RYGB) patients with weight regain undergoing an endoscopy at Bellevue Hospital Center or Brigham and Women's Hospital. investigators aim for a sample size of up to 100 cases. For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope. Then, they will measure the GJA with Napoleon. Investigators will compare the GJA measurements performed using visual estimation and Napoleon. A survey will be given to all endoscopists to assess the level of ease using Napoleon.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

1. RYGB patient with weight regain age 18-90

2. Scheduled for an endoscopy

3. Willingness and ability to provide informed consent

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. History of prior endoscopies with complications

Related Conditions & MeSH terms

• Gastric Bypass
• Weight Regain

Intervention

Device:
• Napoleon
The Micro-Tech Endoscopic Measurement Device named Napoleon is a small catheter with a 30mm ruler calibrated at 1mm intervals with 5mm demarcations. It is classified as a Class 1, 510(k) exempt device by the FDA. The device was originally intended to measure polyps. However, it is used off-label in this study and is considered investigational.

Other:
• Visual estimation
For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Bellevue Hospital Center	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
NYU Langone Health	Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean difference in measured Gastrojejunal Anastomosis size between Napoleon and visual estimation		8 months
Secondary	Proportion of cases with different recommended endoscopic treatment based on GJA size measured by Napoleon Device		8 months
Secondary	Level of ease with using Napoleon in terms of placement, extension/retraction, and photo acquisition		8 months
Secondary	Additional procedure time needed to incorporate use of Napoleon		8 months
Secondary	Proportion of cases with adverse events or unanticipated problems related to use of Napoleon		8 months